Treatment-Resistant Depression (TRD)Depressive DisordersAnxiety DisordersSubstance Use Disorders (SUD)Palliative & End-of-Life DistressSchizophreniaSafety & Risk ManagementSet & SettingPsilocybin

The abuse potential of medical psilocybin according to the 8 factors of the Controlled Substances Act

This review (2018) argues for the safety of psilocybin when used in medical/research settings. The authors recommend rescheduling to Schedule IV (less restrictive than the current Schedule I).

Authors

  • Peter Hendricks
  • Roland Griffiths
  • Matthew Johnson

Published

Neuropharmacology
meta Study

Abstract

This review assesses the abuse potential of medically-administered psilocybin, following the structure of the 8 factors of the US Controlled Substances Act (CSA). Research suggests the potential safety and efficacy of psilocybin in treating cancer-related psychiatric distress and substance use disorders, setting the occasion for this review. A more extensive assessment of abuse potential according to an 8-factor analysis would eventually be required to guide appropriate schedule placement. Psilocybin, like other 5-HT2A agonist classic psychedelics, has limited reinforcing effects, supporting marginal, transient non-human self-administration. Nonetheless, mushrooms with variable psilocybin content are used illicitly, with a few lifetime use occasions being normative among users. Potential harms include dangerous behavior in unprepared, unsupervised users, and exacerbation of mental illness in those with or predisposed to psychotic disorders. However, scope of use and associated harms are low compared to prototypical abused drugs, and the medical model addresses these concerns with dose control, patient screening, preparation and follow-up, and session supervision in a medical facility. Conclusions: (1) psilocybin has an abuse potential appropriate for CSA scheduling if approved as medicine; (2) psilocybin can provide therapeutic benefits that may support the development of an approvable New Drug Application (NDA) but further studies are required which this review describes; (3) adverse effects of medical psilocybin are manageable when administered according to risk management approaches; and (4) although further study is required, this review suggests that placement in Schedule IV may be appropriate if a psilocybin-containing medicine is approved.

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Research Summary of 'The abuse potential of medical psilocybin according to the 8 factors of the Controlled Substances Act'

Introduction

Psilocybin (4-phosphoryloxy-N,N-dimethyltryptamine) is being investigated as a potential treatment for depression and anxiety in patients with life‑threatening cancer, and more preliminarily for treatment‑resistant depression and substance use disorders. The authors frame the current interest in psilocybin against its historical context: marketed briefly in the early 1960s as Indocybin®, its clinical development and research were curtailed by social and regulatory backlash, and psilocybin was placed in Schedule I of the US Controlled Substances Act (CSA) in 1970. Renewed clinical and preclinical work since the 1990s, coupled with modern clinical trial methods and surveillance data, motivates a reassessment of its abuse potential and appropriate scheduling if a psilocybin‑containing drug product were to receive FDA approval. Johnson and colleagues set out to evaluate the abuse potential of medically administered psilocybin using the eight‑factor analysis required by the CSA. The review compiles evidence from preclinical animal studies, human laboratory and clinical trials, historical and ethnographic records, and national surveillance systems to address each CSA factor, and offers a preliminary scheduling recommendation and identification of gaps that would need to be addressed in an NDA‑level abuse potential assessment and supporting programme.

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Study Details

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